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FDA 510(k) Application Details - K051065
Device Classification Name
Irradiator, Blood To Prevent Graft Versus Host Disease
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510(K) Number
K051065
Device Name
Irradiator, Blood To Prevent Graft Versus Host Disease
Applicant
MDS NORDION
447 MARCH RD.
OTTAWA, ONTARIO K2K1X8 CA
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Contact
ROSS KACHANIWSKY
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Regulation Number
000.0000
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Classification Product Code
MOT
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More FDA Info for this Product Code
Date Received
04/26/2005
Decision Date
05/26/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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